Retinal Pigment Epithelial Detachment Secondary to Age-related Macular DegenerationPhase 4NCT02142296
Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular Degeneration (wAMD)
A Phase 4 study testing Eylea in people with Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Primary Objectives: To assess the efficacy of intravitreal administered Eylea in preventing visual loss in subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared to Baseline. Secondary Objectives: 1. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration
- What is being tested?
- Eylea
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed, informed consent.
- Men and women greater than or equal to 55 years of age.
- Recent development of RPED secondary to AMD.
- ETDRS best corrected visual acuities of 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
- Willing and committed and able to return for all clinic visits and complete all study related procedures.
Who cannot join
- Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only)
- Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
- Total lesion size greater than 12 disc areas.
- Subretinal hemorrhage that is either 50% or more of the total lesion area or if the blood is under the fovea and is 1 or more disc areas in size in the study eye.
- Scar or fibrosis making up greater than 50% of the total lesion in the study eye.
- Scar, fibrosis or atrophy involving the center of the fovea.
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- Presence of a retinal pigment epithelial tear.
- History of a vitreous hemorrhage within 4 weeks prior to initiation of the study.
- Presence of other causes of choroidal neovascular membrane other than AMD.
- History of clinical evidence of diabetic retinopathy, especially diabetic maculopathy or macular edema from other causes, including retinal vein occlusion or diabetes
- Prior vitrectomy surgery in the study eye.
- History of retinal detachment treatment in the study eye.
- History of macular hole in the study eye.
- Any intraocular/periocular surgery within 3 months of the initiation of the study.
- Prior trabeculectomy or filtering surgery in the study eye.
- Uncontrolled glaucoma, defined as a pressure greater than 25 mmHg despite treatment.
- Active intraocular inflammation.
- Active ocular/periocular infection.
- Any history of uveitis.
- Active scleritis or episcleritis.
- Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of YAG posterior capsulotomy) in the study eye.
- Previous radiation therapy in the region of the study eye.
- History of corneal transplant or corneal dystrophy in the study eye.
- Significant medial opacities including cataract that may interfere with visual acuity or fundus photography.
- Any disease or ocular condition which, in the opinion of the investigator could either increase in the risk to the subject beyond what is expected from a standard procedure of intraocular injections or which may be considered contraindicated for the use of the investigational drug (VEGF Trap).
- The use of long acting steroids systemically or intraocularly.
- Any history of allergy to Proviodine or fluorescein sodium.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-month, Exploratory Open-label Study of Eylea (Aflibercept) in Subjects With Retinal Pigment Epithelial Detachment Secondary to Neovascular Age-related Macular Degeneration
Primary Objectives:
To assess the efficacy of intravitreal administered Eylea in preventing visual loss in subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared to Baseline.
Read more
Secondary Objectives:
- To assess the safety and tolerability of repeated intravitreal administration of Eylea in subjects with the PED subtype of neovascular AMD for a period of 1 year
- To assess the effect of repeated intravitreal administration of Eylea on Central Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.
- To assess the effect of repeated intravitreal administration of Eylea on vision related quality of life in subjects with PED study type of neovascular AMD assessed using the NEI/VFQ-25 questionnaire
- Being tested
- Eylea
- Keywords
- Pigment Epithelial Detachment, Age-related Macular degeneration
- Medical subject headings
- Retinal Detachment, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyleaDrug
Also called Eylea is the brand name., Aflibercept is the generic name., The DIN is 02415992.
monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml
| Study group | Role | What they receive |
|---|---|---|
| Eylea | Other | The intravitreal dose of Eylea will be 2mg (50ul) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks until week 52. This is an open-label study. Receives: Drug: Eylea |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of Eylea in patients with RPED
visual acuity mean change from baseline compared to month 12
Measured: baseline to month 12
Secondary outcomes (3)
safety and tolerability of repeated Eylea injection
assessment of adverse events at each visit
Measured: period of 1 year
effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume
using OCT (optical coherence tomography) thickness, volume and height will be compared from baseline to month 12
Measured: baseline to month 12
effect of repeated Eyle injections on vision related quality of life
using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12
Measured: baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal Pigment Epithelial Detachment Secondary to Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Gonder, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142296
- Sponsor's protocol ID
- Bayer-001-PED
- Status last verified
- Feb 2017
- First submitted
- 16 May 2014
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Diaconita V, Li B, Pal L, Bahnacy F, Gonder JR. Prospective evaluation of aflibercept in pigment epithelial detachments secondary to neovascular age related macular degeneration. Can J Ophthalmol. 2019 Oct;54(5):626-634. doi: 10.1016/j.jcjo.2019.01.004. Epub 2019 Apr 3.
PubMed 31564356
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Exploratory Open-label Study of Eylea (Aflibercept) in Subjects With Retinal Pigment Epithelial Detachment Secondary to Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02142296
- Acronym / sponsor ID
- Bayer-001-PED
- Keywords
- Pigment Epithelial Detachment, Age-related Macular degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
To assess the efficacy of intravitreal administered Eylea in preventing visual loss in subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared to Baseline.
Secondary Objectives:
- To assess the safety and tolerability of repeated intravitreal administration of Eylea in subjects with the PED subtype of neovascular AMD for a period of 1 year
- To assess the effect of repeated intravitreal administration of Eylea on Central Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.
- To assess the effect of repeated intravitreal administration of Eylea on vision related quality of life in subjects with PED study type of neovascular AMD assessed using the NEI/VFQ-25 questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eylea | Other | Drug: EyleaThe intravitreal dose of Eylea will be 2mg (50ul) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks until week 52. This is an open-label study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed, informed consent.
- Men and women greater than or equal to 55 years of age.
- Recent development of RPED secondary to AMD.
- ETDRS best corrected visual acuities of 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
- Willing and committed and able to return for all clinic visits and complete all study related procedures.
Key exclusion criteria (27 listed)
- Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only)
- Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
- Total lesion size greater than 12 disc areas.
- Subretinal hemorrhage that is either 50% or more of the total lesion area or if the blood is under the fovea and is 1 or more disc areas in size in the study eye.
- Scar or fibrosis making up greater than 50% of the total lesion in the study eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyleaAlso: Eylea is the brand name., Aflibercept is the generic name., The DIN is 02415992.monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml | Drug | Eylea |
Primary outcome
efficacy of Eylea in patients with RPED
Time frame: baseline to month 12
visual acuity mean change from baseline compared to month 12
3 secondary outcomes
safety and tolerability of repeated Eylea injection
Time frame: period of 1 year
effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume
Time frame: baseline to month 12
effect of repeated Eyle injections on vision related quality of life
Time frame: baseline to month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Derived from this study: PubMed 31564356Diaconita V, Li B, Pal L, Bahnacy F, Gonder JR. Prospective evaluation of aflibercept in pigment epithelial detachments secondary to neovascular age related macular degeneration. Can J Ophthalmol. 2019 Oct;54(5):626-634. doi: 10.1016/j.jcjo.2019.01.004. Epub 2019 Apr 3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eylea in people with Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of Eylea in patients with RPED (time frame: baseline to month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02142296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.